Acute Brain InjuryNCT07716787
Brain Monitoring During PEEP-Based Respiratory Therapy in Critically Ill Patients
A study testing Recruitment Maneuver and Positive End-Expiratory Pressure Adjustment in people with Acute Brain Injury and Mechanical Ventilation, run by Shengli Oilfield Hospital at 1 site in China.
Trial summary
Mechanical ventilation is commonly used in critically ill patients with acute brain injury. Positive end-expiratory pressure (PEEP) and lung recruitment maneuvers are important ventilator strategies for improving oxygenation, but they may also influence cerebral blood flow, systemic hemodynamics, carbon dioxide… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injury, Mechanical Ventilation, Neurocritical Care
- What is being tested?
- Recruitment Maneuver and Positive End-Expiratory Pressure Adjustment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Admission to the neurocritical care unit with acute brain injury requiring intensive care management.
- Receiving invasive mechanical ventilation.
- Undergoing clinically indicated recruitment maneuvers and positive end-expiratory pressure (PEEP) adjustments.
- Availability of an adequate temporal acoustic window for transcranial Doppler monitoring.
- Written informed consent obtained from the participant or a legally authorized representative.
Who cannot join
- Pregnancy.
- Hemodynamic instability precluding recruitment maneuvers or PEEP adjustments.
- Severe cardiac dysfunction judged by the treating physician to contraindicate study procedures.
- Inability to obtain adequate transcranial Doppler signals.
- Conditions preventing EEG monitoring, including extensive scalp injury or dressings that preclude electrode placement.
- Withdrawal of informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shengli Oilfield Central Hospital
Dongying, Shandong, 257034
min xu, +86 13864708968, xuminicu@163.com
About this study
Official title: Assessment of Brain Function Changes During PEEP-Based Respiratory Therapy in Critically Ill Patients Using Multimodal Neurophysiological Monitoring
Mechanical ventilation is commonly used in critically ill patients with acute brain injury. Positive end-expiratory pressure (PEEP) and lung recruitment maneuvers are important ventilator strategies for improving oxygenation, but they may also influence cerebral blood flow, systemic hemodynamics, carbon dioxide levels, and brain electrical activity. The effects of PEEP-related ventilator changes on cortical function in neurocritical care patients remain insufficiently understood.
This prospective observational physiological study will evaluate changes in brain electrical activity and cerebral blood flow during clinically indicated lung recruitment maneuvers and PEEP adjustments in mechanically ventilated neurocritical care patients. Multimodal monitoring will include electroencephalography (EEG), transcranial Doppler ultrasound, invasive arterial blood pressure, end-tidal carbon dioxide, and routine clinical variables.
Read more
EEG-derived measures, including delta power ratio and related frequency-domain indicators, will be used to describe cortical activity. Cerebral blood flow velocity and low-frequency neurovascular coupling measures will be explored as secondary physiological outcomes. The study will examine whether PEEP-related changes are associated with alterations in EEG activity, cerebral blood flow, and neurovascular coupling, and whether these responses differ according to clinical status.
The results may help improve understanding of brain-lung interactions during mechanical ventilation and inform future studies on individualized ventilation strategies in neurocritical care.
Read the detailed description
Acute brain injury is frequently accompanied by respiratory dysfunction requiring mechanical ventilation because of impaired consciousness, respiratory insufficiency, or the need for airway protection. Positive end-expiratory pressure (PEEP) and lung recruitment maneuvers (RM) are commonly applied to improve oxygenation and prevent alveolar collapse. Although these interventions are essential components of lung-protective ventilation, increases in intrathoracic pressure may influence venous return, systemic hemodynamics, cerebral perfusion, carbon dioxide homeostasis, and cerebral blood flow. Such physiological alterations may subsequently affect cortical activity and neurovascular coupling, particularly in patients with impaired cerebrovascular regulation. However, the cerebral effects of ventilator interventions remain incompletely understood in neurocritical care populations.
This prospective, single-center study is designed to investigate brain-lung interactions during mechanical ventilation in patients admitted to a neurocritical care unit. The study focuses on the dynamic relationships among ventilator settings, cerebral electrophysiological activity, cerebral hemodynamics, and systemic physiological responses during clinically indicated recruitment maneuvers and PEEP adjustments.
During routine respiratory management, participants will undergo predefined ventilator interventions consisting of recruitment maneuvers and PEEP modifications according to the study protocol. Physiological signals will be continuously recorded throughout baseline, intervention, and recovery periods. This design allows assessment of cerebral responses to controlled changes in intrathoracic pressure and respiratory support while minimizing interference with standard clinical care.
Multimodal physiological monitoring will be performed simultaneously throughout the study period. Monitoring modalities include scalp electroencephalography (EEG), transcranial Doppler ultrasonography (TCD), invasive arterial blood pressure monitoring, end-tidal carbon dioxide monitoring, pulse oximetry, and routine intensive care monitoring. Physiological signals from multiple monitoring devices will be synchronized and recorded using a dedicated multimodal data acquisition platform. High-resolution recordings of cerebral electrophysiological activity, cerebral blood flow velocity, arterial blood pressure, respiratory parameters, and end-tidal carbon dioxide will allow assessment of rapid physiological responses occurring during ventilator interventions. Continuous acquisition of synchronized physiological signals will permit integrated evaluation of respiratory, cardiovascular, and cerebral responses.
EEG recordings will be analyzed using quantitative electrophysiological methods to characterize cortical activity. Spectral analysis will be performed to assess changes across conventional frequency bands, including relative delta activity and other power-based indices reflecting alterations in cortical functional state. Cerebral blood flow dynamics will be evaluated using TCD-derived cerebral blood flow velocity measurements. Simultaneous recordings of arterial blood pressure and end-tidal carbon dioxide will provide complementary information regarding cerebral perfusion and respiratory physiology.
A central component of the study is the investigation of neurovascular coupling during mechanical ventilation. Integrated analysis of EEG activity and cerebral blood flow oscillations will be performed to characterize physiological coupling between neuronal activity and cerebral circulation. Relationships among cerebral electrophysiological activity, cerebral blood flow velocity, systemic hemodynamics, respiratory variables, and ventilator settings will be explored to better understand mechanisms underlying brain-lung interactions. These analyses will provide insight into how ventilator-induced physiological changes may influence cerebral function and cerebrovascular regulation in critically ill patients.
By providing simultaneous assessment of respiratory, hemodynamic, and neurophysiological responses during ventilator interventions, this study aims to improve understanding of the physiological mechanisms linking mechanical ventilation and brain function. The findings may contribute to the development of individualized ventilatory strategies that optimize respiratory support while preserving cerebral physiological stability in patients with acute brain injury.
- Being tested
- Recruitment Maneuver, Positive End-Expiratory Pressure Adjustment
- Keywords
- Mechanical Ventilation, Positive End-Expiratory Pressure, Neurocritical Care, Brain-Lung Interaction, Neurovascular Coupling, Electroencephalography, Transcranial Doppler, Cerebral Blood Flow
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recruitment ManeuverProcedure or surgery
A standardized lung recruitment maneuver performed during mechanical ventilation to transiently increase airway pressure and reopen collapsed alveoli. Physiological responses are continuously monitored using multimodal neuromonitoring and hemodynamic monitoring systems.
Positive End-Expiratory Pressure AdjustmentProcedure or surgery
Positive end-expiratory pressure (PEEP) levels are adjusted according to the study protocol during mechanical ventilation. Cerebral electrophysiological activity, cerebral blood flow, systemic hemodynamics, and respiratory parameters are continuously recorded during PEEP modifications.
| Study group | Role | What they receive |
|---|---|---|
| PEEP-Based Respiratory Intervention | Experimental | Not described Receives: Procedure: Recruitment Maneuver; Procedure: Positive End-Expiratory Pressure Adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EEG Delta Power Ratio During PEEP-Based Respiratory Interventions
Change in electroencephalography (EEG)-derived delta power ratio (DPR) measured before, during, and after recruitment maneuvers and positive end-expiratory pressure (PEEP) adjustments. DPR is calculated as the proportion of delta-band power relative to total EEG power and is used as an indicator of cortical electrophysiological activity.
Measured: During ventilator interventions (baseline, intervention, and recovery periods; approximately 30 minutes)
Secondary outcomes (3)
Change in Cerebral Blood Flow Velocity
Changes in cerebral blood flow velocity measured by transcranial Doppler ultrasonography during recruitment maneuvers and PEEP adjustments.
Measured: During ventilator interventions (approximately 30 minutes)
Change in Neurovascular Coupling Index
Changes in neurovascular coupling quantified by phase-amplitude coupling analysis between low-frequency cerebral blood flow oscillations and EEG activity.
Measured: During ventilator interventions (approximately 30 minutes)
Change in Mean Arterial Pressure
Changes in invasive mean arterial pressure during recruitment maneuvers and PEEP adjustments.
Measured: During ventilator interventions (approximately 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Feb 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants undergo the same study procedures, including recruitment maneuvers and PEEP adjustments during routine mechanical ventilation. Physiological responses are assessed using repeated within-subject measurements obtained before, during, and after ventilator interventions.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengli Oilfield Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, min xu, Shengli Oilfield Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716787
- Sponsor's protocol ID
- XJS-2024-08
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Brain Function Changes During PEEP-Based Respiratory Therapy in Critically Ill Patients Using Multimodal Neurophysiological Monitoring
- ClinicalTrials.gov ID
- NCT07716787
- Acronym / sponsor ID
- XJS-2024-08
- Keywords
- Mechanical Ventilation, Positive End-Expiratory Pressure, Neurocritical Care, Brain-Lung Interaction, Neurovascular Coupling, Electroencephalography, Transcranial Doppler, Cerebral Blood Flow
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shengli Oilfield HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mechanical ventilation is commonly used in critically ill patients with acute brain injury. Positive end-expiratory pressure (PEEP) and lung recruitment maneuvers are important ventilator strategies for improving oxygenation, but they may also influence cerebral blood flow, systemic hemodynamics, carbon dioxide levels, and brain electrical activity. The effects of PEEP-related ventilator changes on cortical function in neurocritical care patients remain insufficiently understood.
This prospective observational physiological study will evaluate changes in brain electrical activity and cerebral blood flow during clinically indicated lung recruitment maneuvers and PEEP adjustments in mechanically ventilated neurocritical care patients. Multimodal monitoring will include electroencephalography (EEG), transcranial Doppler ultrasound, invasive arterial blood pressure, end-tidal carbon dioxide, and routine clinical variables.
EEG-derived measures, including delta power ratio and related frequency-domain indicators, will be used to describe cortical activity. Cerebral blood flow velocity and low-frequency neurovascular coupling measures will be explored as secondary physiological outcomes. The study will examine whether PEEP-related changes are associated with alterations in EEG activity, cerebral blood flow, and neurovascular coupling, and whether these responses differ according to clinical status.
The results may help improve understanding of brain-lung interactions during mechanical ventilation and inform future studies on individualized ventilation strategies in neurocritical care.
Detailed description
Acute brain injury is frequently accompanied by respiratory dysfunction requiring mechanical ventilation because of impaired consciousness, respiratory insufficiency, or the need for airway protection. Positive end-expiratory pressure (PEEP) and lung recruitment maneuvers (RM) are commonly applied to improve oxygenation and prevent alveolar collapse. Although these interventions are essential components of lung-protective ventilation, increases in intrathoracic pressure may influence venous return, systemic hemodynamics, cerebral perfusion, carbon dioxide homeostasis, and cerebral blood flow. Such physiological alterations may subsequently affect cortical activity and neurovascular coupling, particularly in patients with impaired cerebrovascular regulation. However, the cerebral effects of ventilator interventions remain incompletely understood in neurocritical care populations.
This prospective, single-center study is designed to investigate brain-lung interactions during mechanical ventilation in patients admitted to a neurocritical care unit. The study focuses on the dynamic relationships among ventilator settings, cerebral electrophysiological activity, cerebral hemodynamics, and systemic physiological responses during clinically indicated recruitment maneuvers and PEEP adjustments.
During routine respiratory management, participants will undergo predefined ventilator interventions consisting of recruitment maneuvers and PEEP modifications according to the study protocol. Physiological signals will be continuously recorded throughout baseline, intervention, and recovery periods. This design allows assessment of cerebral responses to controlled changes in intrathoracic pressure and respiratory support while minimizing interference with standard clinical care.
Multimodal physiological monitoring will be performed simultaneously throughout the study period. Monitoring modalities include scalp electroencephalography (EEG), transcranial Doppler ultrasonography (TCD), invasive arterial blood pressure monitoring, end-tidal carbon dioxide monitoring, pulse oximetry, and routine intensive care monitoring. Physiological signals from multiple monitoring devices will be synchronized and recorded using a dedicated multimodal data acquisition platform. High-resolution recordings of cerebral electrophysiological activity, cerebral blood flow velocity, arterial blood pressure, respiratory parameters, and end-tidal carbon dioxide will allow assessment of rapid physiological responses occurring during ventilator interventions. Continuous acquisition of synchronized physiological signals will permit integrated evaluation of respiratory, cardiovascular, and cerebral responses.
EEG recordings will be analyzed using quantitative electrophysiological methods to characterize cortical activity. Spectral analysis will be performed to assess changes across conventional frequency bands, including relative delta activity and other power-based indices reflecting alterations in cortical functional state. Cerebral blood flow dynamics will be evaluated using TCD-derived cerebral blood flow velocity measurements. Simultaneous recordings of arterial blood pressure and end-tidal carbon dioxide will provide complementary information regarding cerebral perfusion and respiratory physiology.
A central component of the study is the investigation of neurovascular coupling during mechanical ventilation. Integrated analysis of EEG activity and cerebral blood flow oscillations will be performed to characterize physiological coupling between neuronal activity and cerebral circulation. Relationships among cerebral electrophysiological activity, cerebral blood flow velocity, systemic hemodynamics, respiratory variables, and ventilator settings will be explored to better understand mechanisms underlying brain-lung interactions. These analyses will provide insight into how ventilator-induced physiological changes may influence cerebral function and cerebrovascular regulation in critically ill patients.
By providing simultaneous assessment of respiratory, hemodynamic, and neurophysiological responses during ventilator interventions, this study aims to improve understanding of the physiological mechanisms linking mechanical ventilation and brain function. The findings may contribute to the development of individualized ventilatory strategies that optimize respiratory support while preserving cerebral physiological stability in patients with acute brain injury.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants undergo the same study procedures, including recruitment maneuvers and PEEP adjustments during routine mechanical ventilation. Physiological responses are assessed using repeated within-subject measurements obtained before, during, and after ventilator interventions.
| Arm | Type | Receives |
|---|---|---|
| PEEP-Based Respiratory Intervention | Experimental | Procedure: Recruitment Maneuver, Procedure: Positive End-Expiratory Pressure Adjustment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Admission to the neurocritical care unit with acute brain injury requiring intensive care management.
- Receiving invasive mechanical ventilation.
- Undergoing clinically indicated recruitment maneuvers and positive end-expiratory pressure (PEEP) adjustments.
- Availability of an adequate temporal acoustic window for transcranial Doppler monitoring.
Key exclusion criteria (6 listed)
- Pregnancy.
- Hemodynamic instability precluding recruitment maneuvers or PEEP adjustments.
- Severe cardiac dysfunction judged by the treating physician to contraindicate study procedures.
- Inability to obtain adequate transcranial Doppler signals.
- Conditions preventing EEG monitoring, including extensive scalp injury or dressings that preclude electrode placement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recruitment ManeuverA standardized lung recruitment maneuver performed during mechanical ventilation to transiently increase airway pressure and reopen collapsed alveoli. Physiological responses are continuously monitored using multimodal neuromonitoring and hemodynamic monitoring systems. | Procedure or surgery | PEEP-Based Respiratory Intervention |
| Positive End-Expiratory Pressure AdjustmentPositive end-expiratory pressure (PEEP) levels are adjusted according to the study protocol during mechanical ventilation. Cerebral electrophysiological activity, cerebral blood flow, systemic hemodynamics, and respiratory parameters are continuously recorded during PEEP modifications. | Procedure or surgery | PEEP-Based Respiratory Intervention |
Primary outcome
Change in EEG Delta Power Ratio During PEEP-Based Respiratory Interventions
Time frame: During ventilator interventions (baseline, intervention, and recovery periods; approximately 30 minutes)
Change in electroencephalography (EEG)-derived delta power ratio (DPR) measured before, during, and after recruitment maneuvers and positive end-expiratory pressure (PEEP) adjustments. DPR is calculated as the proportion of delta-band power relative to total EEG power and is used as an indicator of cortical electrophysiological activity.
3 secondary outcomes
Change in Cerebral Blood Flow Velocity
Time frame: During ventilator interventions (approximately 30 minutes)
Change in Neurovascular Coupling Index
Time frame: During ventilator interventions (approximately 30 minutes)
Change in Mean Arterial Pressure
Time frame: During ventilator interventions (approximately 30 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recruitment Maneuver and Positive End-Expiratory Pressure Adjustment in people with Acute Brain Injury and Mechanical Ventilation, run by Shengli Oilfield Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Xu (+8613864708968, xuminicu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EEG Delta Power Ratio During PEEP-Based Respiratory Interventions (time frame: During ventilator interventions (baseline, intervention, and recovery periods; approximately 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.